Publication

Abstract : A 3year 6 months old male child took Combiflam suspension which was a Fixed dose combination (FDC) of ibuprofen 100mg/5ml+ acetaminophen 162.5mg/5ml for otalgia following which he developed maculopapular rashes all over the body associated with pruritis eventually the patient was treated with intravenous antihistamines, antibiotics, oral antihistamines, proton pump inhibitors and topical lotions. The adverse drug reaction was classified as “Probable”(score5) and “Probable/Likely” category as per Naranjo’s algorithm and WHO-UMC causality assessment scale respectively. Severity assessment as per Hartweig’s and Siegel scale classified the reaction as level 3 (moderate) adverse drug reaction. This fixed dose combination suspension is available in India as over the counter (OTC) medication and hence awareness about such incidences needs to be communicated to both patient and physician level in view of patient safety